Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-30

Study Completion Date

2022-03-31

Brief Summary

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Multicentre prospective registry including consecutive patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in which variables related to the percutaneous access closure for implanting devices at aorta level will be collected and analyzed.

The follow-up period will be 30 days after the procedure. The duration of the recruitment period will be one year. All data will be collected telematically and incorporated into a database for subsequent statistical analysis.

There will be 2 points for data interim analysis at 6 and 12 months after initiation of the study.

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Detailed Description

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Conditions

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Aorta Aneurysm Aorta Dissection Aorta Stenosis Aortic Coarctation Aortic Rupture Aortic Valve Disease Aortic Valve Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in who percutaneous access closure device is used for implanting devices at aorta level.

Perclose Proglide (Abbott)

Intervention Type DEVICE

Common Femoral Artery percutaneous access closure by means of Perclose Proglide device

Interventions

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Perclose Proglide (Abbott)

Common Femoral Artery percutaneous access closure by means of Perclose Proglide device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women over 18 years old
* Signed informed consent
* Endovascular procedures on the aorta to any level, performed by percutaneous access and requiring the use of devices ≥ 10F
* Femoral Access suitable for percutaneous treatment in the opinion of the surgeon

Exclusion Criteria

* Need for surgical repair of the femoral artery (stenosis aneurysmal)
* Initial indication of percutaneous closure with another device different from the Perclose Proglide
* Active infection of the puncture site
* Condition that prevents complete the 30 days follow up

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No